Clinical Affairs Manager(a)

On behalf of our Client a well established Medical Device company located in Biel (Switzerland) we are looking for:

Clinical Affairs Manager (f/m/d) 80-100%

 

Tasks

  • Manage all aspects of clinical trials, starting from planning to closeout and reporting
  • Write or contribute to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research-related documents
  • Prepare and submit application dossiers to ECs
  • Interact as an interface between the company and CRO: Ensure that CRO activities and timelines are in coordination with regulatory and project requirements, implement and document communication with CRO and sites to ensure project progress
  • Track and report on study progress including site initiation, subject/patient enrollment, monitoring visits and relevant documents
  • Maintain the EDC system and registry of all study documents
  • Support regulatory affairs in completion of clinical aspects of regulatory applications coupled with international regulatory submissions to appropriate agencies inclusive of CE mark application
  • Conduct all duties in compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements

Profile

  • S. degree in the biomedical sciences or equivalent with four years’ experience in medical, scientific or clinical affairs or Ph.D. with two years’ experience working in clinical research
  • Working knowledge of Good Clinical Practices and experience in basic biostatistics
  • Good understanding of medical device or pharmaceutical business modes and market dynamics
  • Team player, willing to work cross-functionally and understand the perspectives of individuals in other departments
  • Self-starter, able to work independently and self-manage time, goals and tasks
  • Ability to travel approximately 20%
  • Fluent English (C1 – C2), good communication skills in German as an advantage
  • Proficiency in MS-Office-Programs (Excel and PowerPoint)

Antoine Villard
Antoine Villard
Telefon: +41 58 255 31 13

Jetzt online bewerben